FREESTYLE: Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Poorly Controlled Diabetes Type 1 Patients

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03671161

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism Disorders (Including Diabetes Mellitus) Diabetes Mellitus, Type 1	Device: Insulin Pump and flash glucose monitoring	N/A

Detailed Description

This is a non-controlled proof of concept prospective pilot study in adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and started a FGM system (Free Style Libre®) during 6 months, hoping this intervention can reengage patients in self-management, reduce HbA1c without increasing the risk of ketoacidocetosis (DKA) and severe hypoglycemia (SH), and keep the DTSQ (Diabetes Treatment Satisfaction Questionnaire) and HFS (Hypoglycemia Fear Scale) at good levels.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

19 patients with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.19 patients with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day.

Primary Purpose:

Treatment

Official Title:

Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with poorly controlled diabetes type 1 Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day swithced to Insulin Pump and flash glucose monitoring	Device: Insulin Pump and flash glucose monitoring Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.

Arm

Intervention/Treatment

Experimental: Patients with poorly controlled diabetes type 1

Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day swithced to Insulin Pump and flash glucose monitoring

Device: Insulin Pump and flash glucose monitoring

Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.

Outcome Measures

Primary Outcome Measures

Change in HbA1c ≥1% [6 months]
Blood samples at baseline and 6 months
Number of severe hypoglycemia episodes [6 months]
Number of severe hypoglycemia episodes, evaluated by flash glucose monitoring
Number of ketoacidosis episodes [6 months]

Secondary Outcome Measures

Any positive change in DTSQ scale (ΔDTSQM6-DTSQM0>0) (Diabetes Treatment Satisfaction Questionnaire) [6 months]
Filling questionnaires at baseline and 6 months. DTSQ (Diabetes treatment questionnaire) includes 8 items, each score from 0 to 6 with a higher score indicating better outcome
Any positive change in HFS scale (Hypoglycemia Fear Scale) [6 months]
Filling questionnaires at baseline and 6 months. HFS (Hypoglycemia fear scale) assesses participant's fear of hypoglycemia both overall and separately for behavior (10 items) and worry (17 items), both items scoring from 1 to 5, with lower score indicating better outcome
Number of Hypoglycemia episodes [6 months]
Number of hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of hypoglycemia episodes [6 months]
Frequency of hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of severe hypoglycemia episodes [6 months]
Frequency of severe hypoglycemia episodes, evaluated by Flash glucose monitoring
Frequency of ketoacidosis episodes [6 months]
Any changes in Weight [6 months]
Weight measures at baseline 2 months and 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adults with type 1 diabetes, aged between 18 and 55, HbA1c >9% (75 mmol/mol), multi daily insulin injections (MDI) treatment, maximum 2 SMBG /day

Exclusion Criteria:

diabetes with less than 1 year duration, severe active retinopathy requiring laser therapy, severe psychiatric illness, pregnancy, inability to communicate in French, concomitant severe active disease, patients already using a FGM or a CGM